Duns Number:623316978
Device Description: Interbody Fusion Device nanoLOCK Surface Technology 6 Degree Large 11mm
Catalog Number
5386-1611-N
Brand Name
Endoskeleton TCS
Version/Model Number
5386-1611-N
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 21, 2020
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K142940,K153122
Product Code
ODP
Product Code Name
Intervertebral fusion device with bone graft, cervical
Public Device Record Key
b89d2112-f27a-4f43-b3a1-6010a967190e
Public Version Date
December 09, 2020
Public Version Number
7
DI Record Publish Date
January 11, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 243 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5255 |